title: [From the "note limitative" to the "registri AIFA"].
abstract: In Italy, over the past 10 years, we have had a proliferation of registers associated with the reimbursement of drugs by the National Health Service. The regulatory path that made them grow comes from the so-called "note limitative" and treatment plans associated with the use of certain drugs. From these experiences different types of registries have been created that collect, at the time of prescription, information about the safety and appropriateness of use of medication where a benefit-risk profile in the general population is still not well defined. The critical analysis of some of these experiences can present positive and negative aspects associated with a regulatory reality now used in clinical practice nationwide.
authors.affiliation: Area Governance della Ricerca, Agenzia Sanitaria e Sociale Regionale Emilia-Romagna, Bologna. aaddis@regione.emilia-romagna.it
authors.forename: Antonio
authors.initials: A
authors.lastname: Addis
authors.forename: Nello
authors.initials: N
authors.lastname: Martini
mesh_terms: D000544:Alzheimer Disease / Q000188:drug therapy; D000890:Anti-Infective Agents / Q000627:therapeutic use; D002800:Cholinesterase Inhibitors / Q000627:therapeutic use; D004345:Drug Industry; D006801:Humans; D007558:Italy; D011486:Protein C / Q000627:therapeutic use; D011565:Psoriasis / Q000188:drug therapy; D011994:Recombinant Proteins / Q000627:therapeutic use; D012042:Registries; D018805:Sepsis / Q000188:drug therapy
chemical_list: D000890:Anti-Infective Agents; D002800:Cholinesterase Inhibitors; D011486:Protein C; D011994:Recombinant Proteins; C421124:drotrecogin alfa activated